RecruitingUrinary Bladder NeoplasmsNeoplasm MetastasisUreteral Neoplasms

FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3

Eligible age

18+ yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Study participation could last up to approximately 6 years, depending on which part of the study you join.

Sponsor: Eli Lilly and Company

You may qualify if…

✓ Cohort A1, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration.
✓ Cohort A2, B2, B5 and B7: Urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration.
✓ Cohorts B1 and B4: Urothelial cancer that is locally advanced or metastatic and have received prior erdafitinib.
✓ Cohort B6: Muscle Invasive Bladder Cancer with a qualifying FGFR3 alteration.
✓ Cohort B7: Urothelial cancer that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration and expression of human epidermal growth factor receptor 2 (HER2).
✓ Cohort B8: Low Grade Intermediate Risk Non-Muscle Invasive Bladder cancer and a qualifying FGFR3 genetic alteration.
✓ Measurability of disease:
✓ Cohort A1, D1, and D2: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1).

You may not qualify if…

✕ Participants with primary central nervous system (CNS) malignancy.
✕ Untreated or uncontrolled CNS metastases.
✕ Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible.
✕ Any serious unresolved toxicities from prior therapy.
✕ Significant cardiovascular disease.
✕ Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF).
✕ Active uncontrolled systemic infection or other clinically significant medical conditions.
✕ Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled.